Avandia Ordered to Mediation
U.S. District Judge Cynthia M. Rufe stayed the MDL and gave the parties 75 days to resolve at least 85 percent of the cases, which allege that GSK concealed the diabetes medications' potential to cause heart attack and stroke in some patients.
If the 85 percent benchmark is not reached by the deadline, the court will put the first 100 cases filed in the docket on a fast track to a trial, Judge Rufe said. All discovery in those cases will be completed in 60 days, the judge said.
She appointed attorney Patrick A. Juneau Jr. of Juneau David PC in Louisiana to act as mediator.
"I am hopeful that attorneys will want to participate, and that GSK will enter in good faith discussions to bring the cases to resolution," lead plaintiffs' counsel Paul R. Kiesel of Kiesel Law, LLP said.
The pharmaceutical giant has been dogged by private litigation over Avandia, with links to heart attack and strokes spurring thousands of lawsuits that resulted in the company's recording a $3.4 billion legal charge for the fourth quarter of 2010. Many of the suits were consolidated in 2007 into the MDL in the Eastern District of Pennsylvania.
Kiesel said he estimates that about 20,000 cases nationwide are still open, though he said it was difficult to get concrete numbers because GSK has not publicly shared the information.
A representative for GSK could not immediately be reached for comment Tuesday.
GSK's $3 billion settlement, announced Nov. 3, ended a probe by the U.S. Attorney's Office for the District of Massachusetts into the company's marketing practices, as well as the U.S. Department of Justice's investigations into possible violations tied to Medicaid's rebate program and into the marketing of Avandia.
Avandia came under congressional fire in February 2010 when the Senate Finance Committee released a report accusing GSK of trying to quash evidence that suggested it carried a greater risk of heart attack and heart failure than rival drug Actos.
In May, the U.S. Food and Drug Administration announced that it was planning to pull Avandia from retail pharmacies after Nov. 18 and that doctors and patients would need to enroll in an FDA program in order to prescribe and receive the medicine. The European Medicines Agency had already suspended sales of the drug completely in 2010.
For a time, the diabetes drug was the best-selling in the world, netting the drugmaker $1.2 billion in 2009 alone.
Paul R. Kiesel of Kiesel Law, LLP is lead counsel for the plaintiffs in the MDL